Phase I Dose Escalation Study of VS-6063 in Japanese Subjects With Non-Hematologic Malignancies
- Sponsor
- Verastem, Inc.
- Study ID
- NCT01943292
- Phase
- PHASE1
- Status
- Completed
Conditions
- Non Hematologic Cancers
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Defactinib — DRUG
Study Details
This is a phase I, open-label, dose-escalation trial of defactinib (VS-6063), a focal adhesion kinase inhibitor, in Japanese patients with non-hematologic malignancies. The purpose of this study is to assess the safety (including the recommended phase 2 dose), the pharmacokinetics, and the anti-cancer activity of defactinib (VS-6063).
Key Dates
- Start date
- Sep 2, 2013
- Status verified
- Jan 2016
- Primary completion
- Jun 9, 2014
- Completion
- Jun 9, 2014
Study Design
- Enrollment
- 9 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: DefactinibOral defactinib (VS-6063) administered twice a day (BID) during a 21 day cycle.
Primary Outcome Measure
Assess the Safety and Tolerability of Defactinib (VS-6063) in Japanese Subjects With Non-hematologic Malignancies [ Time Frame: From start of treatment to end of treatment, an expected average of 12 weeks ]